Journal Article

Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial

Hong, Young Joon, Han, Ki Hoon, Kim, Dong-Bin, Lee, Kwang-Jae, Lee, Sang Hak, Min, Kyungwan, Kim, Sang Hyun, Won, Kyungheon, Lim, Sang-Wook, Lim, Hong-Seok, Yu, Jaemyung, Kim, In Joo, Hong, Soon Jun, Park, Ie Byung, Lee, Hyoungwoo, Kim, Chee Hae, Byun, Dong Won, Kim, Seok Yeon, Ahn, Chul Woo, Kim, Hyo-Soo, Jeon, Hui Kyung, Han, Kyung Ah, Kim, SeongHwan, Hur, Seung-Ho, Sung, Jidong

2018

Overview

The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment. This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks. A total of 201 patients were analyzed (mean [SD] age, 58.1 [10.7] years; 62.7% male). After 8 weeks of treatment, the percentage change from baseline in triglycerides (TGs) and non–HDL-C was significantly greater in the ROSUMEGA group than in the rosuvastatin group (TGs: −26.3% vs −11.4%, P < 0.001; non–HDL-C: −10.7% vs −2.2%, P = 0.001). In the linear regression analysis, the lipid-lowering effect of ω-3 fatty acids was greater when baseline TG or non−HDL-C levels were high and body mass index was low. The incidence of adverse events was not significantly different between the 2 groups. In patients with residual hypertriglyceridemia despite statin treatment, a combination of ω-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non−HDL-C than rosuvastatin alone. Further study is needed to determine whether the advantages of this lipid profile of ω-3 fatty acids actually leads to the prevention of cardiovascular event. ClinicalTrials.gov identifier: NCT03026933.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Cardiovascular disease / Cholesterol / combination / Coronary vessels / Diabetes / Double-blind studies / Fatty acids / High density lipoprotein / Hypertriglyceridemia / Internal Medicine / Lipids / Low density lipoprotein / non–HDL-C / Omega-3 fatty acids / Placebo effect / rosuvastatin / Statins / Triglycerides / Vitamin B / ω-3 fatty acids